Alpha Tau completes 48-patient IMPACT pancreatic cancer enrolment
Alpha Tau Medical has completed patient enrolment in IMPACT, its multicenter pilot study of Alpha DaRT intratumoral radiation therapy combined with standard first-line chemotherapy for newly diagnosed, unresectable pancreatic adenocarcinoma. A total of 48 patients have been enrolled across ten clinical centres in the United States, Canada and Israel, a figure four times the study's original approved size of 12.
The study expanded three times during recruitment, the final expansion driven by requests from participating clinical sites rather than by the sponsor alone. That trajectory is unusual for a pilot-stage device study and reflects the limited options available to patients with locally advanced or metastatic pancreatic cancer, where up to 87% of cases are considered inoperable at diagnosis. Systemic chemotherapy remains the standard of care, and median overall survival in the metastatic setting is measured in months.
How Alpha DaRT works
Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) uses radium-224 impregnated sources inserted directly into the primary tumour under endoscopic ultrasound guidance. As radium decays, short-lived daughter isotopes disperse within the tumour, emitting high-energy alpha particles over a short range. The mechanism is intended to concentrate radiation damage within the tumour while limiting exposure to surrounding healthy tissue, which is the long-standing obstacle to combining local radiotherapy with full-dose systemic chemotherapy in the pancreatic setting.
IMPACT is conducted under a US Investigational Device Exemption. Enrolled patients receive either mFOLFIRINOX or gemcitabine plus nab-paclitaxel at full systemic dose, with Alpha DaRT delivered as a one-time intratumoral addition at the start of chemotherapy. The primary endpoint is safety, assessed by the cumulative incidence and severity of treatment-emergent adverse events. Secondary endpoints include overall and progression-free survival, pain control, and, in the locally advanced cohort, the rate of surgical resection.
Chief executive Uzi Sofer described the enrolment pace as "probably the fastest enrollment of a study in my memory as CEO," and said the results are intended to inform the design of a planned pivotal study. Chief medical officer Robert Den noted that earlier first-in-human work at Hadassah Medical Center in Jerusalem and at two Canadian centres, whose results were presented at ASCO and Digestive Disease Week in 2026, established a safety profile compatible with concurrent full-dose chemotherapy.
Broader programme and competitive context
IMPACT sits alongside two further European studies: the ACAPELLA trial in France, which evaluates Alpha DaRT as consolidation following first-line mFOLFIRINOX, and a percutaneous-delivery study at the University of Verona's Pancreas Institute. Together, the three studies represent Alpha Tau's attempt to build a global evidence package ahead of a pivotal programme.
Pancreatic cancer is one of the most active areas for novel local and locoregional approaches, with established players in irreversible electroporation and focused ultrasound alongside emerging radiopharmaceutical and immunotherapy combinations. Alpha DaRT's differentiator is the claim that intratumoral alpha emission can be layered onto, rather than substituted for, chemotherapy. Whether IMPACT data in early 2027 support that premise at a clinically meaningful scale will be the pivotal question for investors and regulators alike. A favourable safety readout would clear the path to an IDE pivotal study design meeting with the FDA; an unexpected toxicity signal at full chemotherapy dose would substantially complicate the development narrative.
The study is registered at ClinicalTrials.gov under identifier NCT06698458. Alpha Tau is listed on Nasdaq under the ticker DRTS.